NCT04492007

Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a proof-of-concept pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized supportive care for cancer patients and caregivers during post-treatment care transition.

Detailed description

In this proof-of-concept study, our multidisciplinary team will conduct a pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized supportive care for cancer patients and caregivers during post-treatment care transition. We will randomly assign 21 cancer patients with newly created ostomies for cancer treatment with curative intent and their primary caregivers to the PRISMS or usual care groups (21 patient-caregiver dyads, a total of 42 individuals). PRISMS is defined as a personalized psychoeducational website including monitoring and personal feedback. We will conduct pre- and post-assessments of QOL and PRO (symptoms) at baseline upon enrollment and 2 months later.

Conditions

• Colorectal Cancer
• Bladder Cancer
• Ovarian Cancer
• Cervical Cancer
• Uterine Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)	Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications (e.g., skin infection, fatigue) from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through videoconferencing/telephone from the research nurse and also their healthcare providers at the hospital(s) if they experience moderate to severe symptoms and/or abnormal sign (e.g., body temperature is greater than 98.6 C

Timeline

• Start date: 2020-11-02
• Primary completion: 2021-10-21
• Completion: 2021-12-20
• First posted: 2020-07-30
• Last updated: 2025-02-03
• Results posted: 2025-02-03

Locations

1 site across 1 country: United States